Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)

Royal Marsden NHS Foundation Trust

Status: Unknown

Conditions: Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02503917

CCR4342

Details and patient eligibility

About

This study will establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images using both healthy volunteer and cervical patient cohorts. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Full description

Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.

Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteer cohort: Healthy female adult volunteers
• patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.

Exclusion criteria

• both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study

Trial design

25 participants in 2 patient groups

Healthy volunteers

Description:

Healthy female adult volunteers

Cervical cancer patients

Description:

Patients receiving radiotherapy for cervical cancer at the Royal Marsden who will receive a planning CT scan and daily CBCT scanning as part of their treatment.